FDA Inspection
Fannin UK LtdFannin UK Ltd – FDA Inspection, Mar 26, 2015
Record Details
This FDA Inspection record concerns Fannin UK Ltd, with an inspection on March 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fannin UK Ltd
- Inspection Date
- March 26, 2015
- Product Type
- Devices
View Company Profile
ID · 93c39a10-d40f-4ff2-b438-0adb54ecd036
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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